ISO 13485 Transferring a product from manufacturing facility 1 to manufacturing facility 2

#1
ISO 13485 Transferring a product from manufacturing facility 1 to manufacturing facility 2.

Should a transfer be treated as a new product? Should product engineering be involved.
Our company is working toward ISO 13485 certification and want to comply with 13485.
 

Pjservan

Involved In Discussions
#2
I will say that at the very least you need to confirm that at the new site the following is done: IQ- Installation Qualification, OQ- Operational Qualification and PQ- Performance Qualification. Furthermore for any type of transfer it is recommendable that you also look at customer requirements (usually as Change Control requirements).

All this with the assumption of course, that policies and procedures are the same or equivalent from one site to the other.
 
#3
ISO 13485 Transferring a product from manufacturing facility 1 to manufacturing facility 2.
Should a transfer be treated as a new product? Should product engineering be involved.
.
to flip the question., do you intend to maintain two sites independently!? vs would you treat the site-2 as an alternate site?
( i think scope is now driven by commercials and tactically keeping them independent of each site wrt customers, regulatory inspections etc)

essentially calibrate ENTIRE design controls for site-2; with appropriate assessment and revisiting from design-FMEA onwards to design transfer, design verification etc., ( depending upon the similarities and differences at both facilities) also need to have an Quality agreement if an where the 'design' is revisited at either site to ensure the updates/changes/improvements are reflected at both sites.

for making them independent, there might be additional activities of cloning the design controls + knowledge transfer to respective design teams to make them independent.

note :- i look forward for the device-gurus to comment; I am quite new and few products old in this domain.
 

moounir

Involved In Discussions
#4
Oh my god Brann828,

I am dealing with that question everyday at work and I understand that you struggle. We created a procedure to transfer products from site 1 to site 2 and this is like a checklist. (It's an internal document so cannot share that sorry)
We defined what we think is important for each department with our procedure requirements, test requirements,...

Example:
- Obsolete documents on site 1 and recreate them on the other site
- Confirm if there is a need of validation or verification
- Create the new router on the MRP
- Transfer the Raw material to site 2 and cancel it on site 1

And this is divided on phases (Planning, Implementation, Check and confirmation)

To be clear, this is a great tool to show on an audit. The auditor sees that we really take control of the transfer and this is a WIN.

The issue is that this is a huge work and regarding your question if this is like a New Product Introduction, I would say "Half-Yes"

Because on a new product introduction you have to define all the specification of a product, and test with prototypes and....
But here you already have all that. Unless you change the performance of the product at the same time.

So this is not a full New Product Introduction but it looks like that when you will present that to the team. My team is always complaining that our checklist is 100 lines and this is an important work. But in reality 40% of the list is not applicable. And it's why a planning phase is critical to clean all the things that are not needed. You still need to provide a rational why this is not needed but it's nothing in comparison to do the action.

But without this system, each of our site would perform and transfer in different manner and maybe forget some actions. This could lead to Non-conformities or recall so be careful.

So I hope this answered your question and Good luck.
 

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